A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
Checked against the public recordLast updated Jan 6, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Selpercatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies * Evidence of an activating RET gene alteration in the tumor and/or blood * Measurable or non-measurable disease * Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50 * Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days * Adequate hematologic, hepatic and renal function. * Ability to receive study drug therapy orally or via gastric access * Willingness of men and women of reproductive potential to observe conventional and effective birth control Exclusion Criteria: * Major surgery within two weeks prior to planned start of LOXO-292 * Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 * Active uncontrolled systemic bacterial, viral, fungal or parasitic infection * Clinically significant active malabsorption syndrome * Pregnancy or lactation * Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292) * Uncontrolled symptomatic hypercalcemia or hypocalcemia * Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension * Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor\[s\])
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Childrens Hospital of Los AngelesLos Angeles, California
- The Children's Hospital for Cancer and Blood DisordersAurora, Colorado
- Nemours Children's HealthOrlando, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Minnesota HospitalMinneapolis, Minnesota
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- St. Jude Children's Research HospitalMemphis, Tennessee
- University of Texas Southwestern Medical Center at DallasDallas, Texas
- Texas Childrens HospitalHouston, Texas
- Seattle Children's Hospital Research FoundationSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2026. Always confirm current availability with the study team.